Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

Conditions

• Breast Cancer
• Colon Cancer
• Esophageal Cancer
• Gastrointestinal Cancer
• Genitourinary Cancer
• Head and Neck Cancer
• Healthy Volunteer
• Lung Cancer
• Melanoma
• Prostate Cancer
• Sarcoma
• Skin Cancer
• Solid Tumor Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.

Key Dates

Start date

May 29, 2019

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Healthy Donor Samples
  * Donation of blood and/or urine samples as often as bi-monthly and as many as 24 times in total * These samples will be used to generate reference data to compare patient data to and/or to correct stereotypic noise.
• Arm: Samples from Repository and Banking Studies
  * Healthy prostate and/or blood and/or urine samples from Genitourinary Repository * Tissue, blood, and/or drain fluid samples from Head and Neck Banking studies * Tissue and/or blood samples from Esophageal Repository * Tissue and/or blood samples from Genitourinary Repository * Tissue and/or plasma from Sarcoma Tissue Bank * Tissue and/or plasma from Breast Cancer Bank * Tissue, plasma, and/or urine from GI Tissue and Blood Bank * Tissue, blood, and/or urine from Solid Tumor Bank * Tissue, blood, and/or urine from Lung Cancer Bank * Tissue and/or blood from Skin Cancer Bank * Tissue and/or blood from Pediatric Neurosurgery Tissue Bank

Primary Outcome Measure

Freedom from progression [ Time Frame: Through completion of study (estimated to be 6.5 years) ]

Central Contacts

• Melissa Reimers, M.D.
  314-362-7249
  [email protected]

Locations (1)

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